Patent Bar Exams

May 18, 2015
The Bar Exam by Will Bullas

The Bar Exam by Will Bullas

Wannabee Israel Patent Attorneys will have their chance shortly.

The written exam for drafting patents for computer, electronics and mechanical inventions will take place on 29 June 2015, and the written exam for biological and chemistry inventions will take place on 1 July 2015. The written exams will take place at 9 am and at 3 PM the candidates will have to take a language proficiency exam (unless they obtain a dispensation from this).

oral examination

The oral examinations will take place on Monday 6 July and Thursday 9 July, and candidates are requested to keep both days free, but closer to the time, will be assigned one or other date.

More details may be found here בחינות עופ – יוני 2015.

 

 


Software Rewrites

May 11, 2015

medical software

ICM is a software program designed for doctors, clinics and hospitals. A Mr Yehuda Ungar had the requisite skill set and experience to develop the program and signed a founders agreement with Yaakov Cashdi and others, the result of which was ICM Links Technologies and Information LTD, a company dedicated to creation of the ICM software for managing a medical database.

Cashdi, the other founders and ICM LTD claim that Yehuda Ungar copied and marketed the program to Bircon LTD, infringing their rights and becoming enriched at their expense.

The plaintiffs have sued for a declarative judgment that Ungar has infringed the founders agreement; an accounting regarding Bircon LTD’s use of the program and 750,000 Shekels compensation.

Statement of Case

The plaintiffs, Yaakov, Eli and Milik are shareholders of Ordan Computers and Data Systems which is a software developer that specializes in administrative software for clinics and medical chains.

Yehuda Ungar developed his ICM system that is complimentary to Ordan’s program and Ungar approached Yaakov, Eli and Milik to create a business partnership for the continued development, marketing and sales of ICM in Israel and abroad. Yaakov, Eli and Milik agreed and ICM Links Technologies and Information LTD was established.

Under the agreement, Ungar was to transfer all rights, source code and documentation to the company and to make his experience and medical file management available to the company.

Yaakov, Eli and Milik were to dedicate their resources, knowledge and experience to the program and eventually to market it.
The contract also included a non-complete clause for a minimum of three years and at least six months longer than any of the founders were serving as director, employee or shareholder in the company. The shares were divvied up and all share holders were to serve as directors for at least 24 months.

In 2003, Yehuda Unger met with a Mr Tenne, the manager of a chain of clinics who agreed that the chain could serve as a beta site for the software. The plaintiffs thought that the beta testing was going well, but in March 2004, Unger informed them that Mr Tenne had given notice to stop the trials. The plaintiffs failed to raise investment capital and further development stopped, freezing the company.

Yehuda Unger offered to resign and find alternative employment until a further opportunity would present itself. As a severage package Unger requested the right to compete, and to use ICM’s program whilst remaining a director and shareholder. Yaakov, Eli and Milik refused these conditions and contact between the parties was lost. In July 2008, Yaakov, Eli and Milik discovered that despite being an employee and shareholder, Unger had continued to develop the software together with Mr Tenne through Mr Tenne’s company Bircon LTD, which had marketed the product, earning money for both Unger and Tenne.

Yaakov, Eli and Milik considered Unger’s behavior as breach of contract, unjust enrichment and fraud. They further considered Bircon LTD as guilty of unjust enrichment and copyright infringement and sued for:

  • A declaratory judgment that the program was the property of ICM that Yehuda Unger was in breach of contract and breach of trust as a shareholder and director
  • Copies of accounts regarding the software
  • An injunction against further use
  • 100,000 Shekels in statutory damages and
  • 750,000 Shekels in lost earnings resulting from the breach of contract.

Statement for the Defense
Yehuda Unger is a systems analyst with 30 years of experience in managing software projects. Via his wholly owned company Irit Model, he has been working since 1995 at developing the ICM medical record database platform.

Unger alleges that Yaakov, Eli and Milik approached him in 2002 and suggested that Ordan would market the ICM platform either as stand-alone software or together with their ‘Clinica’ program.

Following this approach, a marketing and joint venture agreement was signed in July 2002. Six months later, Yaakov approached Yuhuda Unger and offered that Yaakov, Eli and Milik would purchase his shares via Ordan.

Under the agreement, via Ordan, Yaakov, Eli and Milik would transfer 40,000 Shekels a month. However, they did not meet this, and in September 2003, they informed Unger that they did not have the resources to fund ICM.

According to Unger, at Bircon, he programmed from scratch using public domain code and his personal knowledge, without using ICM, its source code or other resources. Unger even filed a counter-claim but subsequently retracted it.

The subsequent case relied on testimony from the parties, software engineers of both Ordan and Bircon and Dr Matthew Golani as an expert witness to the court.

Ruling
Ordan marketed Clinica and Irit marketed an early version of ICM to the Eynayim chain of clinics that was under the management of a Dr Levinger. The sides realized that they each had complementary software products that were half a solution and they discussed working together. After negotiations, in July 2002, the parties signed a marketing agreement under which Ordan would market ICM. About six months later, at the beginning of 2003, the sides discussed Ordan purchasing ICM and a framework agreement was signed. Following this, Unger continued working on ICM, but as an employee of Ordan and the code was transferred to Ordan which allocated a programmer to the project and Milik undertook the marketing.

In parallel with the ongoing development work, the parties negotiated a full contract, under which Unger was to be paid “consultancy fees” and a new company was to be set up. The contract was signed in July 2003.

Judge Shwartz summarized the agreement and interpreted the lacuna. and the various parties’ actions in following signing of the agreement.
He found Unger’s programming for Bircon was unjust enrichment, breach of copyright and brach of contract, but held Tenne and Bircon innocent of wrong doing.In Conclusion, Judge Swartz ruled that:

ICM LTD was the right holder in the software.

  • Unger breached the founder’s agreement
  • Unger is forbidden to make any use of the software without permission from ICM LTD.
  • Unger has to pay ICM LTD 100,000 Shekels statutory damages.
  • Unger has to pay costs of 4500 Shekels and 25,000 Shekels legal fees.

47761-11-11 Cashdi et al. vs. Under et al., ruling by Judge Shwartz, 26 April 2015.

COMMENTS
To a large extent, the issue is factual rather than legal. Judge Shwartz has to rely on the agreement as signed to work out what the parties intended.


DSM IP Assets Opposes IL 177724 to Refine Technologies – Striking Evidence from the Record

April 22, 2015
 Selling Culture?


Selling Culture?

Refine Technologies LLC are opposing Israel Patent Numbers 177724 and 205606 to DSM IP Assets. These applications, titled “Methods For Reducing The Degree Of Aggregation Of Aggregating Cells In A Cell Culture” are a national phase entry of PXCT/EP2005.002374 from 4 March 2005 and a divisional application thereof.

The two applications claim priority from EP 04075702.3 and EP 04075703.1 from 5 March 2004, and from EP 04077656.9 and EP 04077657.7 from 27 September 2005. The parent was allowed and published for opposition purposes on 31 January 2011 and on 27 April 2011 Refine technology LLC submitted an Opposition.
The Opposition proceeding was frozen until the divisional application was allowed and that was opposed on 29 November 2011. The two opposition proceedings were combined and the Statements of Opposition and responses were filed for the two cases together.
Both sides submitted expert opinions. In their answer to the Applicant’s response, Mr Jerry Shevitz submitted a second affidavit and the DSM IP Assets allege that this relates to art that wasn’t cited in the original statement of case and also raises new issues. The sections relating to the additional citations and new issues should be struck as an illegitimate widening of the grounds of opposition. Furthermore, they weren’t an answer to the response.
In an additional argument, DSM IP Assets alleged that Mr Jerry Shevitz relied on a decision of the South Korean court concerning a corresponding application and that this was hearsay and thus inadmissible.

Refine Technologies LLC countered that DSM IP Assets waited more than six months after Shevitz’ answer was filed and that it was thus too late to request that the references be struck from the record. They also allege that the claims were in the original statement of case and so rejected that they were illegitimately widening their opposition. They argued that the new citations weren’t new to DSM as they were cited in Korea and were only brought now, due to the response that DSM filed that ignored these references that they were familiar with. Consequently, the new citations were properly to be considered as being an answer to the Applicant’s response. As to the Korean case being a foreign court ruling, the opposer accepted that it wasn’t binding on the Israel Patent Office or in an way precedential, nevertheless it was a relevant ruling on the same issue by a respectable court and was thus admissible comparative law for the commissioner to consider.

DSM objected to the application as lacking novelty in light of US 6,544,424 from 2003, a patent now assigned to DSM. Whilst admitting that this patent did not relate to Refines ATF (alternative tangential flow) technology, they submitted that this was not relevant to the results obtained. DSM further argued that the combination of US 6,544,424 and other prior art renders the claims obvious. For good measure, they also argued that the claimed inventions were not enabled and the claims were inadequately supported.

In her Ruling, the Deputy Commissioner, Ms Jacqueline Bracha acknowledged that the submission to strike evidence could have been submitted earlier, but felt that the three months remaining to DSM before the hearing gives them adequate time to relate to the issue on its merits.

The material that Refine objected to may be categorized into three groups:

  1. Material that could have been referred to in the original opposition
  2. Material that unfairly widens the grounds for opposition
  3. Material that relates to foreign court rulings

Ms Bracha noted that Section 62 of the patent regulations only allows the opposer to file additional evidence to overcome something refuted by the applicant or in response to a new point raised by the applicant. Consequently sections 2, 19.2, 20, 24 and 41, and the related appendices which were considered as new material or widening were ordered struck from the record. As to foreign court rulings, Ms Bracha considered these relevant and helpful and that these could be submitted, whilst noting that she was in no way bound by them.

No costs were awarded.

Intermediate ruling Refines Opposition to DSM IP Assets Opposition to Israel Patent Applications 177724 and 205606, Ms Jacqueline Bracha, 16 March 2015

 


Israel Ranked 3rd in US Patent Filings

April 2, 2015

us patent3rd place

Israel originating patents filed in the US jumped 21 percent in 2014, according to a study by BdiCoface.

The study found that 3,555 Israel-based patents were filed in the US during 2014,which is nearly 389 patents per million Israeli inhabitants. Only Japan, with 445.6 patents per million, and Taiwan, with 524.4 patents per million, outranked Israel, which was ahead of South Korea, Switzerland, Sweden and Finland.

From 2009 to 2013, the companies filing the most US patents for Israeli inventions were IBM (674 patents), followed by Intel (435), Marvell (281), Sandisk (261) and HP (197). The top educational institutions in Israel filing US patents were Tel Aviv University (161), the Weizmann Institute (158), the Technion (137) and the Hebrew University of Jerusalem (116). These statistics are high compared to other universities abroad and is seems that Israel’s tech transfer policy is working.

Probably due to the relatively high cost, there has been a drop in European Patent Applications for Israeli inventions.

We note that the US is a preferred location for Israel inventors who may not bother filing in Israel. For fast moving industries such as telecommunications, it may make sense only filing in the US. For methods of medical treatments or after the inventor has published or presented his invention in public, there may be no alternatives. Nevertheless, we consider not filing in Israel may be a costly mistake. Often Israel has more than one company in the same technology area. Current employees may become competitors. Enforcing a patent in Israel is much cheaper than enforcement in the US and the costs of also filing and prosecuting in Israel may be minimal. Finally, with the PPH (Patent Prosecution Highway) first filing in Israel may speed up the process of obtaining a patent in the US.

We also note that patents and patent applications are not apples and oranges. The absolute numbers and even numbers per capita are statistics of doubtful value as some patents are worth billions and most aren’t worth the cost of obtaining them. That is true even if they are exceptionally well written, simply because some technologies are implemented and others are obsolete when filed.

I do recommend that my Israel based clients seriously consider filing in Israel. Apart from odd Judaica related inventions and other niche products, most file in the US.  China is taking over from Europe as a primary destination, but Europe, Korea and Japan are all popular. Australia and India are also on the patent map.

The correct strategy of where to file and indeed of what to file is very case specific and depends on a number of variables including but not limited to budget, business plan, technology field, the centrality of the patent to the company, the size of potential and actual markets and where competitors are domiciled.

 


Patent Office Closures for Pesach

March 26, 2015

pesach cleaning

The Israel Patent Office will be closed from 3rd April 2015 to 11 April 2015 for Pesach (Passover), and will open again for business on 12 April 2015.

Deadlines falling during the period that the Israel Patent Office is closed are automatically extended until 12 April 2015.

However, trademarks and PCT Applications may be filed on line during the festival and will receive the date that they are filed. Notwithstanding this, according to discussion with Dr Michael Bart, the USPTO now accepts PCT applications that are filed late due to Israel Patent Office closures.


Sony Clamps Down on Pirate Computer Games

March 26, 2015

Pirate
Sony Entertainment sued Azam Gever claiming copyright infringement and unjust enrichment, alleging that Gever’s computer shop “McKan Computers” on the main road through Osefiya sold fake disks with games for the Sony Playstation console.
In his defense, Gever claimed to be ignorant of the fact that the disks he was selling were not originals. If Gever could successfully convince that he was unwittingly distributing fake disks, he would not be held responsible. If, however, this defense collapsed, he would be held responsible for damages.
Sony claimed to have copyright in the Playstation and Playstation 2, and in software for the Playstation. They also claimed to own trademarks 95025 and 95026 for Playstation. Sony Entertainment Europe was responsible for distributing in Europe, the Middle East, Africa and the Pacific Rim and franchised distribution rights for the software within those territories, including Israel.
Playstation programs can only be played using the Playstation interface due to special encryption. Any copying, burning to disk of a Playstation game will, inter alia, include copying of the encryption which is copyright infringement of Sony’s copyright. Sony claimed that they are in a perpetual war to prevent their software from being pirated, and that they have spent enormous sums in advertising and promoting the console, They have copyright notices on the disks, on the packages, and appearing on screen.
The defendant did not deny selling pirate CDs but denied knowing that they were pirate copies. Sony sent a private investigator to the shop to see what was being sold. The private investigator and his son testified that they were both independently told that the programs were copies, and that the owner had shown a box of bundles of 50 disks, containing 3 or 4 copies of each game. The private investigator testified that he bought five different games at 10 shekels ($2.50) each, paid 50 Shekels and received a tax invoice for 50 Shekels that indicated thatit was for Sony II disks. The private investigator filmed the visit and submitted the footage as an exhibit. The games purchased included Beyond Good and Evil, Dragon’s Quest, God’s hand, Spy Hunter, and Fifa 2013.
The Plaintiff alleged that inspection of the disks showed clearly that they were fakes that infringed Sony’s Copyright since they were not in cardboard packages with shrink-wrapped cellophane or new DVD boxes and did not include instruction booklets. Unlike the originals, the disks did not have pictures on them and were not stamped with Sony’s logo and copyright notice. Sony sent a Cease & Desist letter and asked for the pirated disks to be handed over and for accounts to be produced for calculating profits and infringement revenue. The parties were, however, unable to come to an amicable settlement and so this case was filed. In the statement of case, Gever was accused of copying or creating fraudulent copies, selling or offering to sell these in the course of his business, offering to sell and holding fake copies thereby infringing the copyright, without permission of Sony and without compensating Sony.
In addition to the copyright charges, Sony alleged unjust enrichment under the law of Unjust Enrichment 1979 and various trade related torts for damaging Sony’s reputation.
Sony sued for compulsory damages of 100,000 Shekels per infringement under Section 56a of the Copyright Law 2007. Claiming years of fraud, Sony requested increased damages of 150,000 Shekels and also applied for an injunction against Gever to prevent him from selling fake disks directly or indirectly.
Gever laconically acknowledged ownership of the shop and that he’d sold programs against the tax invoice, but denied selling or trading in fake software. Gever further alleged that he’d bring expert witness that the software was genuine.
In the preliminary hearing, Gever repeated that the disks were genuine and that he was unaware of “the material”. In a second preliminary hearing he again requested to examine the disks. After the parties held a brief discussion, the attorney for the plaintiff stated that the defendant claims that he sells computers, disks is a mere sideline that produces at most, 1% of income and that if it should transpire that the disks are indeed fake, he was unaware of this. In Gever’s own statement under cross-examination, he complained that he wasn’t warned, that he only sells a handful of disks each month and never claimed that they were originals. His lawyer clarified that the intention was to state that his client was unaware that the disks were not real. Meanwhile, the private investigator testified that there were a number of disks with the name of the program marked in permanent ink and that when discussing Playstation 3, the vendor had stated that copying it was problematic. Gever claimed that there weren’t more than 30 disks and that this wasn’t a commercial number. He admitted selling computers for 13 years and that he had sold Playstations for at least a decade, but claimed to sell very little software.
Under cross-examination, Gever claimed to obtain and sell original software on a request basis and to sell a handful of fakes each month. Some his brother supplied, some a friend, not sure from where, some he’d copied himself. He denied selling 60 a year, or 600 over the decade. He considered this non-commercial as he had a limited range of maybe 20 games.
The plaintiff requested to correct the statement of case to request 250,000 Shekels damages, alleging that even at the rate of 5 disks a month, this adds up to hundreds of disks over a decade. (I feel a lawyer joke coming on. It seems that neither the judge, not the attorneys were able to do the calculation).
The defendant objected to the sum being corrected. He also alleged that for sales prior to the new copyright law coming into effect in 2008, the maximum statutory damage is 10,000 Shekels (or 20,000 Shekels for willful infringement.

RULING
Despite Regulation 92 of the Civil Court Procedures 1984 allowing extensive corrections to the statement of case to enable the point of contention to be clarified, correcting the sum after the hearing and before ruling is not allowed as it does nothing to clarify the legal issues and will merely protract the proceedings. The plaintiffs alleged that Gever had sold tens if not hundreds of fakes over a period of years and nothing had changed, so the maximum sum claimed remains 150,000 Shekels.
Judge Weinstein ruled that merely selling fake disks was insufficient to be responsible, but the seller had to be aware that they were fakes. In this instance, some he’d scanned himself, others were supplied from an unknown source so it seems clear that he was aware. Furthermore, a computer seller would be expected to be able to differentiate between originals and fakes. The price of 10 Shekels a game was also a fair indication that they were fake.
The private investigator’s footage showed boxes of 50 or more games, and this was a commercial number. The private investigator’s testimony was sufficient to indicate that the vendor was aware that the goods were fake. However, the issue is moot as during cross-examination he admitted copying some of the programs himself.
The problem, was, as always, the burden of proof required. After humming and hawing about the need to warn others not to copy, the admitted sales of small amounts over time and the evidence of 5 separate games, Ms Weinstein ruled damages of 50,000 Shekels and costs of 10,000 Shekels.
52260-01-14 Sony vs. Gever, Ruling Judge Weinstein 16 March 2015

COMMENT
The disks were sold in Osefiya by Shfaram. In the past, a DVD copying factory was discovered in Kiryat Ata.
Personally, I am inclined to believe that Gever sold very little software. Why should anyone not picky about purchasing originals pay 10 shekels if blank DVDs cost half a shekel and everyone has a disk burner?
Not allowing the sum claimed to be increased is one thing, but I think that on the burden of evidence and not requiring actual damages, but statutory damages, Ms Weinstein had sufficient evidence to rule the 150,000 Shekels damages. Not unreasonable for a sideline operating 10 years.


IL 142809 to Pharmacia Successfully Opposed by Teva Pharmaceuticals

March 18, 2015

R&R          R&R2

IL 142809 to Pharmacia AB was submitted on 25 April 2001 as a national phase entry of PCT/SE/99/02052 “NEW CONTROLLED RELEASE BEAD, A METHOD OF PRODUCING THE SAME AND MULTIPLE UNIT FORMULATION COMPRISING IT”. This published as WO 0027364 on 11 November 1999. The application claims priority from another PCT application filed a year earlier.
On allowance in 2006, the patent published for opposition purposes and on 18 May 2006 Teva filed an Opposition, submitting a detailed statement of case on 18 October 2006. On 12 march 2007 Pharmacia filed a counter-statement. Both sides submitted evidence, held a hearing before then Deputy Commissioner Noah Shalev Shmulovich and then filed their summaries.

As per regulation 202a, the current commissioner, Asa Kling ruled on the opposition based on the material of record.

The application is directed to a bead with controlled release of active ingredients, a method of manufacture and a multi-part formulation that includes the active ingredients. Essentially, the bead comprises a multilayer structure that includes a soluble core covered with non-soluble coatings, and the patent has 23 claims, two of which are independent.

Claim 1 is as follows:

 A controlled release bead comprising:
A core unit of a substantially water-soluble or water-swellable inert material;
A first layer on the core unit of a substantially water-insoluble polymer;
A second layer covering the first layer and containing an active ingredient; and
A third layer of polymer on the second layer effective for controlled release of the active ingredient,
Wherein said first layer is adapted to control water penetration into the core.

Claims 2-7 recite the various lawyers and their formulations and thicknesses. Claim 8 is a Markush claim for various active ingredients. Claims 9and 10 claim different forms of the active ingredient. Claim 10 claims use in vitro. Claims 11-14 claim different materials for the first three coatings. Claim 15 provides dimensions for the core and claims 16 and 17 claim multidose structures.

Claim 18 recites a corresponding method as follows:

 A method of producing a controlled release bead, which method comprises the steps of:
providing a core unit of a substantially water-soluble or water swellable material;
applying a first layer of a substantially water-insoluble polymer to said core;
applying onto said first layer, a second layer comprising an active ingredient and optionally a polymer binder; and
applying onto said second layer, a third polymer layer effective for controlled release of the active ingredient;
Wherein the amount of material in said first is selected to provide a layer thickness that permits control of water penetration into the core.

Claims 19, 21 and 23 claim use of the bead for a treatment for various diseases and claims `19 and 21 claim the active ingredient as tolderene or a salt thereof.

Grounds for Opposition
The opposition was based on lack of inventive step (obviousness) under section 5 of the Israel Patent Law 1967. In addition, Teva claimed that some of the claims lack utility contrary to Section 3, that some of the claims lack support from the specification in contravention to Section 13 and the Application is laconic and contravenes Section 12.
Pharmacia argued that claiming that the specification was laconic was an inadmissible widening of the Statement of Case, but the Commissioner, Asa Kling felt that the alleged inadequacy of the specification was inherent in the Statement of Case and that Pharmacia related to the issue so he considered it admissible.
As to inventive step, the Commissioner explained that if at the time of filing, the claimed invention was a simple extrapolation that could be considered as a simple development within the field and allowing a patent for it would prevent progress, it would be incorrect to allow a patent.
The Commissioner noted that both sides accepted that beads allowing controlled release of active ingredients that comprised a miscible or non-miscible core, a sealcoat, layers of active ingredients and additional layers were known at the filing date. The sealcoat serves to protect the active ingredient from reaction with the core and may be water impervious or slightly pervious. In the present invention such water penetration was controlled but in the prior art it was less controlled.

Not that kind of seal coat

Not that kind of seal coat

The present invention differs from the prior art in two ways: (i) the sealcoat is miscible in the prior art but is immiscible in the present invention, and (ii) the seal coat of the present invention is rather thicker than usual, but the thickness is not mentioned in the claim-set.

Teva argued that since the core in this case is impervious the sealcoat is superfluous and non-functional and there is no effective difference from the core of the present invention and that of the prior art.

Teva argued that in the priority document this was stated explicitly:

“Each bead comprises (i) a core unit of a water-soluble, water-swellable or water-insoluble inert material (having a size of about 0.05 to 2 about 2 mm), such as e.g. a sucrose sphere; (ii) a first layer on the core of a substantially water-insoluble (often hydrophilic) polymer (this layer may be omitted in the case of an insoluble core, such as e.g. of silicon dioxide), (iii) a second layer of a water-soluble polymer having an active ingredient dissolved or dispersed therein, and (iv) a third polymer layer effective for controlled release of the active ingredient (e.g. a water-insoluble polymer in combination with a water-soluble polymer)”. (WO0012069 page 6 line 33 to page 7 line 6). This point was also clear from US 6,770,295 to the same applicants.

The Applicant countered that the opposer’s explanation of the phrase “control water penetration into the core” was a misrepresentation and the correct explanation is found on page 2 lines 23-25 of the Application and only rates to beads wherein the water penetration to the core is impeded in a controlled manner and excludes beads where the core is protected by an impervious layer. The Applicant argued that the claim of lack of inventive step was based on this wrong interpretation.  In contradistinction to immiscible cores of the prior art in the present invention the core is miscible and is protected by a partial barrier sealcoat which allows controlled release.
The applicant could not explain the working of the sealcoat and how it inhibited release of the active ingredient but argued that the phenomenon exists and this is sufficient for both enablement and inventive step.
It seems therefore, that the key question is whether an immiscible core or a miscible core protected by an immiscible coating are equivalent or if a miscible core protected by an immiscible coating can be considered inventive over an immiscible core. Citing 345/87 Hughes Aircraft vs. State of Israel, it is accepted that a mere scintilla of invention is sufficient, and the question is whether this exists in the present case.

Utility
Teva argued that the utility was not demonstrated in contravention of Section 3 which allows patents for inventions that are new, useful, industrially applicable and non-obvious.
In oppositions, the onus is on the applicant to show utility. Citing 665/84 Sanofi vs, Unipharm the commissioner stated that the application as field has to provide a basis for utility and, if challenged, the Applicant has to prove utility during opposition proceedings. IN enforcement and cancellation proceedings the burden of proof switches and the challenger has to show a lack of utility. Consequently, the Commissioner ruled that without proof of usefulness a patent should not be granted.

According to the Specification, there are three advantages:

  • The claimed bead prevents the soluble core from serving as a reservoir of the active ingredient and extending the controlled release period
  • It reduces the likelihood of the core material releasing active ingredients and reduces the atmospheric pressure (specific vapour pressure?) and prevents the core from swelling
  • It reduces the initial phase during which there is no release of the active ingredient or only minimal release

According to the applicant these advantages transcend specific active ingredients.

The Opposer argued that these advantages are claimed for the specific active ingredient and for other non-specified active ingredients without any rationale or evidence.

Evidence
The evidence from each side consisted of expert opinions. Teva produced an expert opinion from Professor Golomb, and Pharmacia releid on expert opinions from Professor Wilson and from a Professor Walther who attempted to reproduce the experiments described in the application.
Professor Walther conducted a number of experiments to demonstrate that claimed in the first example for different active biological compounds. These, together with raw data were appended to Professor Walther’s affidavit at the Commissioner’s request.
There were differences between the raw data and the final conclusions with regard to what active species showed the desired effects and whether a heat treatment affected the results. The Commissioner felt that the discrepancies required explanation.
The Applicant claimed that Tolterodine exhibited the desired behavior, as did Reboxetine and cona, theopheylline and Carbamazepine. This was held sufficient to show that the behavior was a general phenomenon.
The tests related to a core with three coatings whereas the specification proposed a fourth optional coating. This, together with other discrepancies were considered to show light on the utility.
The thick initial layer did show slow release of the Tolterodine in a manner that was close to linear.
In the Application, after three hours some 70% of the active ingredient ws released, but in Dr Walther’s corroborative experiments, after this time lapse, only 43% of the active ingredient had been released.
When comparing Professor Walther’s results with the experiments in the specification it appears that the applicant had problems repeating their own experiments. The problem seems to be that Professor Walther simplified the experimental design and still could not achieve meaningful results. He was able to show that a thicker coating impeded release of the active ingredient but not in a qualifiable and repeatable manner.
As far as Tolterodine, the preferred active ingredient was concerned, Professor Walther was unable to show a correlation between thickness and the rate of release and was unable to repeat the examples in the Application. The Commissioner considered the lack of repeatability an reproducibility as undermining the claimed utility and barring the issuance of a patent.
Adequacy of the Specification
Section 12 requires that the specification be adequate to allow persons of the art to implement the invention. The rationale for granting a patent is in exchange for teaching something useful and failure to teach something sufficiently to allow the teaching to be repeated is considered as invalidating the application: “The sufficiency of a specification is a question of fact and necessarily depends upon the nature of the invention and attributes of the skilled person.” ( Hollister [1993] R.P.C. 7 para. 10-14). In this instance, the purpose of the patent as specified in the priority document was to enable the controlled release of the active ingredient at a predetermined rate over the shelf life of the product.
“An important aspect of all controlled release dosage forms relates to the need for consistent drug release between dose units prepared in the same and/or in different production batches, and throughout the shelf-life of the finished product.”

The surelease polymer specified in the specification and used by Professor Walther in his experiments was supposed to provide repeatable and reproducible results:

“In one embodiment, the invention provides a commercial-scale process for manufacture of controlled-release dosage units. The process comprises co-formulating tolterodine or a tolterodine-related compound as an active drug and a pharmaceutically acceptable polymer-based release-controlling component. … more preferably substantially all of the polymer-based release-controlling component used in the process has an age, at time of dosage unit manufacture, which varies by not more than about 180 days, preferably not more than about 120 days, and more preferably not more than about 90 days.”

Professor Walther was unable to show this control. Under cross-examination he stated that:

“So what we know is that Surelease has lot to lot variability. So one batch of Surelease may perform slightly different from another batch of Surelease. That is an effect that the suppliers do know and understand and that is something that, as part of any formulation development, you would establish how robust a product is towards variability and providing sufficient specifications then on it.”

The problem is that this variable is not described in the specification, rendering the claimed invention not enabled.
The Commissioner ruled that the claimed invention does not have demonstrable superiority, lacked sufficient disclosure and enablement and that no inventive step was shown. Consequently the application was refused.

COMMENT
Active ingredients are released from the surface of solids. This is true for components that leach out and for components that are released when a carrier dissolves.
As particles shrink, the surface area to volume ratio increases and the rate of dissolution increases. Having a non-functioning core surrounded with a coating containing active ingredients is to ensure that the effective surface area remains more or less constant and thus the active ingredients are released at a constant rate.
The above explanation is obvious to anyone with a background of materials science and chemistry.
Drugs are more effective if the dosage is released slowly at a constant and predictable rate.
The present invention seems to be based on the premise that over time the core will absorb the active ingredient and that a coated absorbent core is better than a non-absorbent one.
The application is based on Tolterodine as an active material, but other pharmaceutical compounds may be expected to behave in the same way.
Of course, using the same binder and beads of constant diameter won’t give reproducible results if there are other significant variables. The problem here is that the Applicant’s own attempts to demonstrate the efficacy of the claimed invention failed. In such circumstances, the Commissioner couldn’t really have come to a different conclusion than that the application was deeply flawed as the person of the art selected by the applicant was unable to reproduce the results.

The previous Deputy Commissioner resigned four years ago. Obviously this was only one case of many that the current commissioner and his deputy or adjudicator had to rule on. Nevertheless, it seems to me intolerable that the parties should have to wait for four years for this ruling and one wonders why the previous deputy commissioner couldn’t have left less abruptly, and finished these pending cases.

 


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